VERSANT HBV DNA 1.0 Assay (kPCR)

Performance to Meet Your Needs

The VERSANT HBV DNA 1.0 Assay (kPCR) is a real-time polymerase chain reaction (PCR) assay for quantitative detection of human hepatitis B virus (HBV) DNA in plasma or serum of HBV-infected individuals. The assay is intended to be used in conjunction with clinical presentation and other laboratory markers of disease status to aid in the management of HBV-infected individuals undergoing antiviral therapy.

Optimal Standardization

Referenced to the WHO 2nd Hepatitis B Virus (HBV) DNA International Standard (NIBSC 97/750) for IU/mL

Conversion factor: 1 IU/mL = 1.4 copies/mL

Dynamic Range

13-700,000,000 IU/mL

Limit of detection (LOD) = 13 IU/mL

Total Precision (including lot-to-lot variation)

2 log IU/mL – 30.3 to 34.6% (0.13 - 0.16 log SD)

3-4 log IU/mL – 22.3 to 29.1% (0.10 - 0.13 log SD)

5-9 log IU/mL – 20 to 30.9% (0.09 - 0.13 log SD)

Ordering Information

Catalog No. Description

10282480 VERSANT HBV-1 DNA 1.0 (kPCR) Kit, IVDD Box 1 (48 tests) *

10282481 VERSANT HBV-1 DNA 1.0 (kPCR) Kit, IVDD Box 2 (48 tests) *

10286026 VERSANT Sample Preparation 1.0 Reagents Box 1 (96 tests) *

10286027 VERSANT Sample Preparation 1.0 Reagents Box 2 (96 tests) *

*IVDD, CE marked. Not available for sale in the U.S. Product availability varies from country to country and is subject to local regulatory requirements.

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Related Products, Services & Resources

The products/features (mentioned herein) are not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed. Please contact your local Siemens organization for further details.